Testing of pharmacopoeial ethanol (disinfectant ethanol)

disinfectant ethanol

Ethanol has antimicrobial properties and is sold as a disinfectant product at optimized concentrations. Quality control of alcohol as a medical product is carried out through verification testing methods stipulated by various pharmacopoeias. As part of an agreement, the procedures for verification testing of ethanol or anhydrous ethanol in disinfectants are roughly the same in the Japanese (JP), United States (USP) and European (EP) pharmacopoeias.

 

Verification test – component identification via the infra-red absorption spectrum

In the verification testing of ethanol and anhydrous ethanol, identification of components is carried out using Fourier Transform Infrared (FTIR) spectrophotometer. Reference spectra are compared with the spectra of the target compounds. The Japanese Pharmacopeia (JP) specifies a liquid membrane technique test, and below is a measurement example of ethanol and anhydrous ethanol using a liquid cell (KRS-5 window disk).

the infra-red absorption spectrum

 
 

Purity test – analysis of volatile impurities

Volatile impurities in ethanol are detected with a gas chromatograph (GC). Methanol, acetaldehyde, acetal, benzene, etc. are checked as impurities. An appropriate instrument configuration is required to detect the specified 2 vol ppm limit of trace benzene and obtain good separation for acetaldehyde and methanol (separation of 1.5 or higher). The testing of disinfectant ethanol is covered under the general protocol for purity testing of ethanol.

 

Chromatogram of Standard Solution for Ethanol for Disinfection (Overlaid Data from Three Continuous Analyses)

Chromatogram of Standard Solution for Ethanol for Disinfection (Overlaid Data from Three Continuous Analyses)

Chromatograms of Ethanol for disinfection, Sample Solution and Standard Solutions (1) – (4)

Chromatograms of Ethanol for disinfection, Sample Solution and Standard Solutions (1) – (4)

 
 
 
 

UV absorbance test – impurity analysis

The absorbance spectrum of an ethanol sample is used to test for the presence of impurities. A UV-Vis spectrophotometer is used at a wavelength range of 235-340 nm with water as a reference sample. The absorbance at three points (240 nm, 250-260 nm, 270-340nm) is checked as being below certain tolerance values (0.40, 0.30, and 0.10 respectively).

UV absorbance test

 
 
 

Alcohol Concentration Test for Disinfectants

It is important to control alcohol levels in alcohol-based hand sanitizers in order to ensure constant performance. WHO recommends that hand sanitizers be prepared with an aqueous solution containing 80 % ethanol (v/v) and 75 % isopropyl alcohol (v/v). The section on ethanol for disinfection in the Japanese Pharmacopoeia states that hand sanitizers contain 76.9 ~ 81.4 % ethanol (v/v) (under conditions of 15℃).
USP and JP specify distillation and gas chromatography (GC) as methods for measuring alcohol concentration, with GC able to accurately measure ethanol concentration. A Fourier Transform Infrared (FTIR) spectrophotometer can be used to more easily measure alcohol concentration.

ethanol,

Chromatogram of ethanol concentration with GC

IR Spectra of Brand A and B with 60% and 80% Ethanol Standards(left) 
and Brand C and Brand D with 60% and 80% IPA Standards (right)

FTIR allows quick and easy quantification of components included in alcohol disinfectants. The contents of ethanol and isopropyl alcohol, which are commonly used in alcohol disinfectants, were measured.

 
 
 
 
 
 
FTIR Spectroscopy

FTIR Spectrophotometer

Despite their small footprint, smaller than an A3 size sheet of paper, these models have been engineered with a wide sample compartment that accommodates existing accessories from Shimadzu and other manufacturers. This capability makes them the smallest (installation footprint) and lightest FTIR spectrophotometers in the world that can be used with optional products from other manufacturers.

Gas Chromatography

Gas Chromatograph

Nexis GC-2030, Shimadzu's premier gas chromatograph, offers a modern approach to a classic chromatographic technique. Designed with the user in mind, new innovative features, exceptional performance and high-throughput capabilities will elevate your lab to the next level.

UV-Vis Spectrophotometer

UV-Vis Spectrophotometer

The UV-1900i is a double-beam UV-Vis Spectrophotometer using Shimadzu's original LO-RAY-LIGH diffraction grating technology. This instrument can not only run checks for nine JIS items, but also those stipulated in the Japanese Pharmacopoeia (JP), United States Pharmacopeia (USP), and the European Pharmacopoeia (EP).

For Research Use Only. Not for use in diagnostic procedures.

This page may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country.

Top of This Page